Archive for March, 2012

Editor's Choice Academic Journal Main Category: Heart Disease Also Included In: Genetics;Medical Devices / Diagnostics Article Date: 16 Mar 2012 - 9:00 PDT

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Using a gene analysis tool called the Cardiochip, the researchers examined a specific gene variant associated with inflammation and heart disease. The chip was designed by Brendan J. Keating, Ph.D., co-author of the study and a researcher in the Center for Applied Genomics at The Children's Hospital of Philadelphia.

Even though researchers are aware of the association between inflammation and atherosclerosis - a disorder in which fat, cholesterol, and other fatty deposits build up in the walls of arteries - they have been unable to find an inflammatory agent that causes the diseases, until now. In addition, researchers did not know whether a drug targeted at reducing inflammation might treat the disease.

The team focused on the signaling protein interleukin-6 receptor (IL6R). IL6R is found in the blood and increases inflammatory responses.

Keating explained:

The meta-analysis study was conducted by the IL6R Mendelian Randomization Analysis Consortium, and international team of investigators led by Dr. Juan Pablo Casas, Professor Aroon. D. Hingorani, and Dr. Daniel I. Swerdlow, all of University College London, UK.

The researchers examined data from 40 previous studies that involved almost 133,500 individuals from Europe and the United States. Mendelian randomization is a research technique that utilizes knowledge of genes and biological mechanisms in order to figure out the likely effects of a new medication before a clinical trial is conducted, with its potential risk of adverse effects and high cost.

In the same issue of The Lancet, an associated report conducted by the IL6R Genetics Consortium and Emerging Risk Factors Collaboration, discovered that a genetic variant of the IL6R gene, which carries the code for the IL6R protein, decreases inflammation and therefore reduces the risk of heart disease.

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Gene Chip May Help Prevent Heart Disease

A team of Stanford researchers has unveiled the most detailed biological profile of a human being done so far: a peek at one man's genetic foundation, along with snapshots, taken dozens of times over the course of a year, of the millions of proteins and other molecules that are in constant flux in his body.

In a stroke of shocking good luck - for the scientists, if not necessarily the patient - the profile subject developed Type 2 diabetes during the study, allowing researchers to follow in real time the molecular changes that took place as the illness progressed.

It also allowed the subject, Stanford geneticist Michael Snyder, to catch his diabetes early and stop it, most likely months or even years before he would have been diagnosed without the genetic profiling.

"This is the first time someone's actually analyzed the genome of a healthy person, predicted disease risk, and then by following him, actually saw a disease develop," said Snyder, who in addition to being the subject of the study was the senior author.

Snyder's profile and an analysis of the results were published today in the journal Cell. Snyder, chairman of the genetics department at Stanford, is not named in the published study because of privacy rules, but he volunteered to identify himself.

The research provides some of the first proof that detailed genetic profiling - beyond just DNA sequencing - could be used someday not just to predict an individual's chances of developing disease, but also to identify the smallest molecular changes that show when a person starts to become ill, said experts in personalized medicine.

The first human genome - a map of all of the DNA in a human cell - was announced in 2000. Seven or eight years later geneticists began mapping the genomes of specific individuals. Such personal genomic sequencing is expected to become widely available this year, at a cost of several thousand dollars.

Using genetic information to help diagnose and treat patients is still a very new field, although it's growing rapidly. Certain key genes have been found to greatly increase the risk of breast cancer, for example, or the deadly Huntington's disease, and doctors will regularly test for those genes when someone is diagnosed with an illness or when a close family member is known to have a disease.

But for most people, DNA sequencing and other biological profiling isn't yet useful - subjects would end up with a lot of unwieldy information that is mostly beyond modern scientific understanding or far too expensive to analyze.

"What they did (at Stanford) is much more interesting from a scientific basis than a practical basis," said Dr. David Witt, a medical geneticist at Kaiser San Jose. "And that gets to the heart of personalized medicine: It's not ready for prime time."

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Stanford gene researchers see diabetes develop

15-03-2012 12:52 Personalized Medicine: trends and prospects for the new science of genetic testing and molecular diagnostics Overview of new working paper -- Mapping the Future of Genetic Testing and Molecular Diagnostics: A payer's perspective on integrating personalized care into clinical practice Review of results of survey of consumers and physicians about genetic testing Deneen Vojta, UnitedHealth Group

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Personalized Medicine, UnitedHealth Group - Video

15-03-2012 14:59 What is the relationship between implementation guidelines and reimbursement? Are payers the ultimate gatekeeper? Is it worth educating healthcare providers and patients? • Appropriate uses of genetic testing • Evidence-based guidelines and flexibility • Clinical management of new technology • Best practices (eg, breast cancer) Moderator: Robert Green, Harvard Medical School Robert McCormack, Veridex/J&J Thomas Musci, Novartis Diagnostics Greg Feero, Maine - Dartmouth Family Medicine Residency and NHGRI Deborah Heine, Claire Altman Heine Foundation

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Integrating new genetic testing technologies into clinical pathways - Video

15-03-2012 16:33 This panel will consider the context for evidence, rather than the level of evidence, needed to move innovative technology into a clinical setting and how we will generate the needed evidence. Which evidence questions must be answered pre- market and which, if any, can be answered post-market? It will consider the often mismatched evidence requirements of patients, clinicians, test developers, regulators and payers. Collectively, we should define a burden of evidence that's appropriate for the balances of risk and speed that is appropriate in this space. This will require community-wide cooperation to collect and analyze data residing in many different places -- inside pharmaceutical companies, inside diagnostics companies and payers -- to measure outcomes and define the best use of diagnostics, and innovative methodologies to generate evidence (both in process and results). Moderator: Adam Berger, Institute of Medicine Patricia Deverka, Center for Medical Technology Policy Stanley Lapidus, SynapDx Susan Friedman, Facing Our Risk of Cancer Empowered David Clifford, PatientsLikeMe Roger Klein, University of South Florida Medical School

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Evidence - Video

A team of Stanford researchers has unveiled the most detailed biological profile of a human being done so far: a peek at one man's genetic foundation, along with snapshots, taken dozens of times over the course of a year, of the millions of proteins and other molecules that are in constant flux in his body.

In a stroke of shocking good luck - for the scientists, if not necessarily the patient - the profile subject developed Type 2 diabetes during the study, allowing researchers to follow in real time the molecular changes that took place as the illness progressed.

It also allowed the subject, Stanford geneticist Michael Snyder, to catch his diabetes early and stop it, most likely months or even years before he would have been diagnosed without the genetic profiling.

"This is the first time someone's actually analyzed the genome of a healthy person, predicted disease risk, and then by following him, actually saw a disease develop," said Snyder, who in addition to being the subject of the study was the senior author.

Snyder's profile and an analysis of the results were published today in the journal Cell. Snyder, chairman of the genetics department at Stanford, is not named in the published study because of privacy rules, but he volunteered to identify himself.

The research provides some of the first proof that detailed genetic profiling - beyond just DNA sequencing - could be used someday not just to predict an individual's chances of developing disease, but also to identify the smallest molecular changes that show when a person starts to become ill, said experts in personalized medicine.

The first human genome - a map of all of the DNA in a human cell - was announced in 2000. Seven or eight years later geneticists began mapping the genomes of specific individuals. Such personal genomic sequencing is expected to become widely available this year, at a cost of several thousand dollars.

Using genetic information to help diagnose and treat patients is still a very new field, although it's growing rapidly. Certain key genes have been found to greatly increase the risk of breast cancer, for example, or the deadly Huntington's disease, and doctors will regularly test for those genes when someone is diagnosed with an illness or when a close family member is known to have a disease.

But for most people, DNA sequencing and other biological profiling isn't yet useful - subjects would end up with a lot of unwieldy information that is mostly beyond modern scientific understanding or far too expensive to analyze.

"What they did (at Stanford) is much more interesting from a scientific basis than a practical basis," said Dr. David Witt, a medical geneticist at Kaiser San Jose. "And that gets to the heart of personalized medicine: It's not ready for prime time."

Original post:
Stanford man's genetic profile yields surprises

ScienceDaily (Mar. 15, 2012) A collaborative discovery involving Kansas State University researchers may improve animal health and save the U.S. pork industry millions of dollars each year.

Raymond "Bob" Rowland, a virologist and professor of diagnostic medicine and pathobiology, was part of the collaborative effort that discovered a genetic marker that identifies pigs with reduced susceptibility to porcine reproductive and respiratory syndrome, or PRRS. This virus costs the U.S. pork industry more than $600 million each year.

"This discovery is what you call a first-first," Rowland said. "This discovery is the first of its kind for PRRS but also for any large food animal infectious disease. I have worked in the field for 20 years and this is one of the biggest advances I have seen."

Rowland and researchers Jack Dekkers from Iowa State University and Joan Lunney from the Agricultural Research Service discovered a genetic marker called a quantitative trait locus, or QTL, which is associated with porcine reproductive and respiratory syndrome virus susceptibility. This discovery is a first step in controlling and eliminating the virus.

The research recently appeared in the Journal of Animal Science. The project's beginning and future center around Kansas State University, Rowland said.

It begins at the university because Rowland is involved with an organization called the PRRS Host Genetics Consortium, or PHGC, which initiated and provided more than $5 million for the research. Rowland is co-director of the consortium, which is a collaboration among the United States Department of Agriculture, the National Pork Board and Genome Canada as well as universities and industry members. Rowland is also director of the USDA-funded PRRS Coordinated Agriculture Project, known as PRRS CAP.

"The PRRS Host Genetics Consortium takes fundamental science and turns it into utility," Rowland said.

Kansas State University's new Large Animal Research Center is the site of much of the project's experimental work. The researchers obtain multiple measurements -- including growth, weight gain, performance and virus measurements -- over time. They have collected samples from more than 2,000 pigs since they began the study in 2007, for a total of more than 100,000 samples that are stored or distributed to the consortium's collaborators.

The university shipped samples to the Agricultural Research Service for genomic DNA preparations to identify differences among more than 60,000 genes. The data was transferred to Iowa State University for genetic analysis that led to the discovery of the QTL.

The collaborators at Iowa State University created a common database so that all the data collected during the project can be accessed at multiple locations by researchers and the breeding industry for the next several decades.

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Animal health breakthrough: Research uncovers genetic marker that could help control, eliminate PRRS virus

Editor's Choice Academic Journal Main Category: Lymphoma / Leukemia / Myeloma Also Included In: Cancer / Oncology;Genetics Article Date: 16 Mar 2012 - 9:00 PDT

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Ross Levine, M.D., lead author of the study, member of Memorial Sloan-Kettering's Human Oncology Pathogenesis Program, and a medical oncologist on the Leukemia Service at Memorial Sloan-Kettering, said:

We also want to use existing therapies more intelligently. It helps a great deal to know which subset of patients will actually benefit from intensive therapies, such as a higher dose of chemotherapy or a bone marrow transplant."

Currently, there are just a few known genetic biomarkers that clinicians rely on in order to predict outcome in individuals suffering with leukemia. Although these biomarkers provide helpful information for some patients with AML, for the majority it is hard to predict the chance for a cure.

The researchers used a method that incorporated information from a set of genes. This allowed them to categorize almost two-thirds of patients into clearly defined prognostic groups.

Dr. Levine, explained:

"Our goal was not to ask whether a certain gene or two raised or lowered risk, but to determine whether a combination of characteristics from a set of genes made it possible to precisely stratify patients according to risk."

The team examined blood or bone marrow samples from 502 individuals with AML who took part in a clinical trial conducted by Martin S. Tallman, M.D., Chief of Memorial Sloan-Kettering's Leukemia Service. The aim of the trial was to determine whether increasing the standard dose of chemotherapy would improve survival for individuals with AML under the age of 60.

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Leukemia Patients' Outcomes Predicted With Genetic Profiling

PHILADELPHIA A growing body of evidence underscores the importance of human gut bacteria in modulating human health, metabolism, and disease. Yet bacteria are only part of the story. Viruses that infect those bacteria also shape who we are. Frederic D. Bushman, PhD, professor of Microbiology at the Perelman School of Medicine at the University of Pennsylvania, led a study published this month in the Proceedings of the National Academy of Sciences that sequenced the DNA of viruses -- the virome -- present in the gut of healthy people.

Nearly 48 billion bases of DNA, the genetic building blocks, were collected in the stools of 12 individuals. The researchers then assembled the blocks like puzzle pieces to recreate whole virus genomes. Hundreds to thousands of likely distinct viruses were assembled per individual, of which all but one type were bacteriophages viruses that infect bacteria -- which the team expected. The other was a human pathogen, a human papillomavirus found in a single individual. Bacteriophages are responsible for the toxic effects of many bacteria, but their role in the human microbiome has only recently started to be studied.

To assess variability in the viral populations among the 12 individuals studied, Bushman's team, led by graduate student Samuel Minot, looked for stretches of bases that varied the most.

Their survey identified 51 hypervariable regions among the 12 people studied, which, to the team's surprise, were associated with reverse transcriptase genes. Reverse transcriptase enzymes, more commonly associated with replication of retroviruses such as HIV, copy RNA into DNA. Of the 51 regions, 29 bore sequence and structural similarity to one well-studied reverse transcriptase, a hypervariable region in the Bordetella bacteriophage BPP-1. Bordetella is the microbe that causes kennel cough in dogs.

BPP-1 uses reverse transcriptase and an error-prone copying mechanism to modify a protein to aid in entering and reproducing in a wide array of viral targets. Bushman and colleagues speculate that the newly discovered hypervariable regions could serve a similar function in the human virome, and microbiome, by extension.

"It appears there's natural selective pressure for rapid variation for these classes of bacteriophages, which implies there's a corresponding rapidly changing environmental factor that the phage must be able to quickly adapt to," says Minot. Possible reasons for change, say the authors, include evading the immune system and keeping abreast of ever-evolving bacterial hosts a kind of mutation-based host-pathogen arms race. Whatever the case, Minot says, such variability may be helping to drive evolution of the gut microbiome: "The substrate of evolution is mutation."

Evolutionary analysis of the 185 reverse transcriptases discovered in this study population suggests that a large fraction of these enzymes are primarily involved in generating diversity. Now, Minot says, the challenge is to determine the function of the newly discovered hypervariable regions, and understand how their variability changes over time and in relationship to disease.

"This method opens a whole new world of 'diversity-generating' biology to discover what these clearly important systems are actually doing," he says.

In addition to Bushman and Minot, co-authors are Stephanie Grunberg (Department of Microbiology); Gary Wu (Division of Gastroenterology); and James Lewis (Department of Biostatistics and Epidemiology), all from Penn.

The research was supported by grants from the National Institutes of Health, Pennsylvania Department of Health, and the Crohn's and Colitis Foundation of America.

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Genetic Variation in Human Gut Viruses Could be Raw Material for Inner Evolution, Perelman School of Medicine Study ...

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) Dealing with incidental findings uncovered in whole-genome and whole-exome sequencing studies has been a contentious issue in the move to bring next-generation sequencing into the clinic.

A paper published today in Genetics in Medicine finds that physicians generally agree that those findings should be returned to adult patients, especially when medical intervention is possible. They differ, however, in their opinions on whether the findings should be returned to pediatric patients.

"This is the first study to ask specialists in genetics and laboratory medicine about the conditions they would like to see returned to clinicians who order genome sequencing," Robert Green, a geneticist at Brigham and Women's Hospital and Harvard Medical School and co-leader of the study, said in a statement. "It was heartening that the majority of specialists agreed that many incidental findings should be returned."

Co-led by Green and Howard Jacob, director of the human and molecular genetics center at the Medical College of Wisconsin, the researchers surveyed 16 genetics specialists on their recommendations for returning genetic information.

The specialists were questioned about whether they would return known pathogenic mutations, mutations that were likely to be pathogenic, and variants to known disease genes but with unknown consequences, from 99 genetic conditions and disease predisposition genes.

Around 80 percent of the specialists agreed on the return of known pathogenic mutations for 64 different diseases, and all of them agreed on the return of results for 21 different conditions for things like cancer risk and other diseases where there is the potential for medical intervention.

Opinions differed however, on returning results to children. For instance, while all the participants agreed that known variants conferring risk for hereditary breast and ovarian cancer should be returned to adults, only 75 percent thought that information should be shared with children.

Additionally, there was less agreement about what to do with findings that predicted risk for diseases for which there are no treatments, such as Huntington's disease or Alzheimer's.

Around 60 percent of the specialists said that known mutations in the genes for Huntington's disease should be returned to adults, but only 31 percent thought those findings should be returned to children. Half thought that mutations to APOE, which suggests a predisposition to Alzheimer's, should be returned to adults, while 25 percent said that the finding should be returned to children.

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Incidental Findings from Sequencing Studies Should be Returned, Say Genetics Specialists

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-351-0896 Genetics Society of America

Bethesda, MD March 15, 2012 -- A new research report appearing in the March 2012 issue of the journal Genetics shows why the development of a cure and new treatments for HIV has been so difficult. In the report, an Australian scientist explains how he used computer simulations to discover that a population starting from a single human immunodeficiency virus can evolve fast enough to escape immune defenses. These results are novel because the discovery runs counter to the commonly held belief that evolution under these circumstances is very slow.

"I believe the search for a cure for AIDS has failed so far because we do not fully understand how HIV evolves," said Jack da Silva, Ph.D., author of the study from the School of Molecular and Biomedical Science at the University of Adelaide in Adelaide, Australia. "Further insight into the precise genetic mechanisms by which the virus manages to so readily adapt to all the challenges we throw at it will, hopefully, lead to novel strategies for vaccines and other control measures."

To make this discovery, da Silva used computer simulation to determine whether, under realistic conditions, the virus could evolve as rapidly as had been reported if the virus population started from a single individual virus. This was done by constructing a model of the virus population and then simulating the killing of virus-infected cells by the immune system, along with mutation, recombination and random genetic changes, due to a small population size, affecting viral genes. Results showed that for realistic rates of cell killing, mutation and recombination, and a realistic population size, that the virus could evolve very rapidly even if the initial population size is one.

"A cure for HIV/AIDS has been elusive, and this report sheds light on the reason," said Mark Johnston, Ph.D., Editor-in-Chief of the journal Genetics. "Now that we know HIV rapidly evolves, even when its population size is small, we may be able to interfere with its ability to evolve so we can get the most out of the treatments that are developed."

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ABOUT GENETICS: Since 1916, Genetics has covered high quality, original research on a range of topics bearing on inheritance, including population and evolutionary genetics, complex traits, developmental and behavioral genetics, cellular genetics, gene expression, genome integrity and transmission, and genome and systems biology. Genetics, the peer-reviewed, peer-edited journal of the Genetics Society of America is one of the world's most cited journals in genetics and heredity.

ABOUT GSA: Founded in 1931, the Genetics Society of America (GSA) is the professional membership organization for scientific researchers, educators, bioengineers, bioinformaticians and others interested in the field of genetics. Its nearly 5,000 members work to advance knowledge in the basic mechanisms of inheritance, from the molecular to the population level. The GSA is dedicated to promoting research in genetics and to facilitating communication among geneticists worldwide through its conferences, including the biennial conference on Model Organisms to Human Biology, an interdisciplinary meeting on current and cutting edge topics in genetics research, as well as annual and biennial meetings that focus on the genetics of particular organisms, including C. elegans, Drosophila, fungi, mice, yeast, and zebrafish. GSA publishes Genetics, a leading journal in the field and a new online, open-access publication, G3: Genes|Genomes|Genetics. For more information about GSA, please visit http://www.genetics-gsa.org. Also follow GSA on Facebook at facebook.com/GeneticsGSA and on Twitter @GeneticsGSA.

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Computer simulations help explain why HIV cure remains elusive

AMES, Iowa, March 15, 2012 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK - News), today announced that financial results for the company's fourth quarter and year ended December 31, 2011 will be released after the market closes on Thursday, March 29, 2012. The NewLink management team will host a conference call discussing the company's financial results and recent developments on Thursday, March 29, 2012 at 5:00 p.m. (EDT). The call can be accessed by dialing (877) 303-6919 (domestic) or (253) 237-1194 (international) five minutes prior to the start of the call and providing the passcode 62462759. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international), providing the passcode 62462759. The replay will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the NewLink website at http://investors.linkp.com/. A replay of the webcast will be archived on the company's website for two weeks following the call.

About NewLink Genetics Corporation

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. NewLink's portfolio includes biologic and small-molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed with an objective to harness multiple components of the innate immune system to combat cancer, either as a monotherapy or in combination with current treatment regimens, without incremental toxicity. NewLink's lead product candidate, HyperAcute Pancreas cancer immunotherapy is being studied in a Phase 3 clinical trial in surgically-resected pancreatic cancer patients (patient information is available at http://www.pancreaticcancer-clinicaltrials.com). This clinical trial is being performed under a Special Protocol Assessment with the U.S. Food and Drug Administration. NewLink and its collaborators have completed patient enrollment for a Phase 1/2 clinical trial evaluating its HyperAcute Lung cancer immunotherapy product candidate for non-small cell lung cancer and a Phase 2 clinical trial for its HyperAcute Melanoma cancer immunotherapy product candidate. NewLink also is developing d-1-methyltryptophan, or D-1MT, a small-molecule, orally bioavailable product candidate from NewLink's proprietary indoleamine-(2, 3)-dioxygenase, or IDO, pathway inhibitor technology. Through NewLink's collaboration with the National Cancer Institute, NewLink is studying D-1MT in various chemotherapy and immunotherapy combinations in two Phase 1B/2 safety and efficacy clinical trials. For more information please visit http://www.linkp.com.

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NewLink Genetics Announces 2011 Fourth Quarter and Year-End Conference Call and Webcast

Newswise Infants with Batten disease, a rare but fatal neurological disorder, appear healthy at birth. But within a few short years, the illness takes a heavy toll, leaving children blind, speechless and paralyzed. Most die by age 5.

There are no effective treatments for the disease, which can also strike older children. And several therapeutic approaches, evaluated in mouse models and in young children, have produced disappointing results.

But now, working in mice with the infantile form of Batten disease, scientists at Washington University School of Medicine in St. Louis and Kings College London have discovered dramatic improvements in life span and motor function by treating the animals with gene therapy and bone marrow transplants.

The results are surprising, the researchers say, because the combination therapy is far more effective than either treatment alone. Gene therapy was moderately effective in the mice, and bone marrow transplants provided no benefit, but together the two treatments created a striking synergy.

The research is reported online in the Annals of Neurology.

Until now, this disease has been refractory to every therapy that has been thrown at it, says senior author Mark Sands, PhD, professor of medicine and of genetics at the School of Medicine. The results are the most hopeful to date, and they open up a new avenue of research to find effective therapies to fight this devastating disease.

The combination therapy did not cure the disease, the scientists caution, but mice that received both treatments experienced significant, lasting benefits.

Mice that got gene therapy and a bone marrow transplant lived nearly 18.5 months, more than double the lifespan of untreated mice with the disease. (Healthy laboratory mice live about 24 months.) And for a significant portion of their lives, motor skills in mice that got both therapies were indistinguishable from those in normal, healthy mice.

While bone marrow transplants carry significant risks, especially in children, the researchers say they may be able to combine gene therapy with another treatment to achieve the same results. This same approach potentially could be used to treat other forms of Batten disease.

Batten disease is an inherited genetic disorder that strikes fewer than five of every 100,000 U.S. children but is slightly more common in northern Europe. There are several forms of the disease, diagnosed at different ages, and all are related to the inability of cells to break down and recycle proteins.

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Combination Treatment in Mice Shows Promise for Fatal Neurological Disorder in Kids

The professor leading a trial in cystic fibrosis treatment said that there is "huge excitement" about a new type of gene therapy.

Professor Eric Alton, UK Cystic Fibrosis Gene Therapy Consortium Coordinator from Imperial College, told the Today programme's Justin Webb that his team is "excited and enthused" but insisted that it was important not to hype the potential breakthrough.

The trial is being funded by the National Institute for Health Research and the Medical Research Council and it is hoped that it will ultimately lead to a cure for the inherited disorder which affects around 9,500 people in the UK and 90,000 around the world.

Professor Alton told the Today programme's Justin Webb that the "biggest snag is the evolution of the lungs" which, as well as preventing germs and infections from getting in, also stop gene therapy from being effective, so his team has spent the last decade trying to find "tricks to slip the gene in."

"This is difficult science that needs to be built up gradually," he said. But if it is successful the scientists involved could "book their tickets to Stockholm to pick up their Nobel Prize".

Get in touch with Today via email , Twitter or Facebook or text us on 84844.

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AUDIO: 'Exciting' new cystic fibrosis therapy

Michael Snyder observed the onset of his type 2 diabetes while following a range of physiological variables.

S. Fisch

The future of personalized genomic medicine can be glimpsed today in a paper that reports the integration of lead author Michael Snyder's genomic sequence with other omics to give a read-out on his predisposition to disease, and his bodys response to viral infections and the onset of type 2 diabetes1.

As a proof-of-principle example of personalized genomic medicine, it is distinct from other studies because it applies whole-genome diagnostics to a healthy person rather than to individuals with disease.

Snyder, a geneticist at Stanford University School of Medicine in California, joins the swelling ranks of researchers who have publicly aired their own genome sequence. Some scientists question whether the latest work has much to add to the field. Richard Gibbs of Baylor College of Medicine in Houston, Texas, has humorously dubbed it the narciss-ome.

"A criticism of this paper is that its anecdotally about one person, but thats also its strength, says geneticist George Church of Harvard Medical School in Boston, Massachusetts. Large-scale association studies trying to tease out the genetic variants of complex disease often make the mistake of trying to achieve statistical significance by lumping together an enormous number of people that dont necessarily belong together, says Church.

Snyders integrative personal omics profile dubbed iPOP was created by merging his genomic sequence with RNA, protein, metabolic and auto-antibody profiles taken 20 times over a 14-month period. The results revealed Snyder to be genetically predisposed to type 2 diabetes, despite his having no family history or other risk factors. During the study, his blood glucose levels escalated following the second of two viral infections, and he was subsequently diagnosed with the disease. Snyder has since made drastic dietary and lifestyle changes to manage his blood sugar levels.

Snyder and his colleagues followed the changes in real time and report the activation of molecular pathways not previously implicated in viral infection or the onset of type 2 diabetes. By doing longitudinal studies of many more individuals as they transition through healthy and disease states, Snyder thinks it will be possible to uncover new mechanisms involved in disease and the bodys immune and stress responses.

Church agrees. We need more practise looking at individuals. Medicine treats people as individuals and we should be conducting research with a similar attitude. In 2006, Church initiated the Personal Genome Project to sequence the genomes of 100,000 volunteers including his own, which was one of the first ten to be analysed.

Snyder thinks it is ridiculous that standard medical evaluations, or 'work-ups', examine only a few dozen biomedical markers when current technology can generate a multitude more his paper reports more than 3 billion measurements of molecular components. However, interpreting such a vast amount of data for multiple individuals would cause a bottleneck. To this end, Snyder was one of the founders who last August launched Personalis, a company based in Palo Alto, California, with the aim of interpreting genomes for research groups.

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The rise of the 'narciss-ome'

02-03-2012 11:56 more GOOD NEWS like this here: goo.gl Techniques like this, using our OWN STEM CELLS, not someone else's, are the answer to ALL medical problems including DENTAL. Yes you can even seed new teeth from your own DNA... Tell everyone you know to create the demand for the most personalized medicine possible, ie those using your OWN DNA !!!

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TITE INVERSION© -The Skin Gun - Video

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) PeaceHealth, a Washington state-based non-profit health system, has partnered with the P4 Medicine institute, or P4Mi, a non-profit consortium focused on applying personalized medicine in the clinic, the partners announced today.

PeaceHealth said that its partnership with P4 Medicine, which was launched in 2010 by the Institute for Systems Biology and The Ohio State University, will ultimately provide its network of medical centers in Washington, Alaska, and Oregon with new genome-based predictive and diagnostic tools.

The non-profit said that it will work with P4Mi leaders to identify pilot projects that will be launched over the next two years in its medical practices and communities.

P4Mi is centered around the vision of advancing what Leroy Hood, ISB co-founder and president and chairman of P4Mi's board of directors, calls P4 medicine healthcare that is predictive, preventive, personalized, and participatory.

"PeaceHealth will help us integrate emerging biologic science into community-based care models, and make innovations in wellness and health accessible to whole communities," Hood said in a statement.

"Over time, we hope to take rapidly emerging P4Mi health and wellness innovations and integrate them into everyday interactions between PeaceHealth providers and their patients to better predict, prevent, and treat disease," added Peter Adler, PeaceHealth's senior VP for strategy, innovation, and development.

The partnership agreement makes PeaceHealth a founding community health partner of P4Mi, along with OSU's Center for Personalized Health at the Wexner Medical Center.

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Washington's PeaceHealth Joins ISB-led Personalized Medicine Initiative

ScienceDaily (Mar. 15, 2012) Geneticist Michael Snyder, PhD, has almost no privacy. For more than two years, he and his lab members at the Stanford University School of Medicine pored over his body's most intimate secrets: the sequence of his DNA, the RNA and proteins produced by his cells, the metabolites and signaling molecules wafting through his blood. They spied on his immune system as it battled viral infections.

Finally, to his shock, they discovered that he was predisposed to type-2 diabetes and then watched his blood sugar shoot upward as he developed the condition during the study. It's the first eyewitness account -- viewed on a molecular level -- of the birth of a disease that affects millions of Americans. It's also an important milestone in the realization of the promise of truly personalized medicine, or tailoring health care to each individual's unique circumstances.

The researchers call the unprecedented analysis, which relies on collecting and analyzing billions of individual bits of data, an integrative Personal "Omics" Profile, or iPOP. The word "omics" indicates the study of a body of information, such as the genome (which is all DNA in a cell), or the proteome (which is all the proteins). Snyder's iPOP also included his metabolome (metabolites), his transcriptome (RNA transcripts) and autoantibody profiles, among other things.

The researchers say that Snyder's diabetes is but one of myriad problems the iPOP can identify and predict, and that such dynamic monitoring will soon become commonplace. "This is the first time that anyone has used such detailed information to proactively manage their own health," said Snyder. "It's a level of understanding of health at the molecular level that has never before been achieved."

The research was published in the March 16 issue of Cell. Snyder, who chairs the Department of Genetics, is the senior author. Postdoctoral scholars Rui Chen, PhD, George Mias, PhD, Jennifer Li-Pook-Than, PhD, and research associate Lihua Jiang, PhD, are co-first authors of the study, which involved a large team of investigators.

The study provides a glimpse into the future of medicine -- peppered with untold data-management hurdles and fraught with a degree of self-examination and awareness few of us have ever imagined. And, despite the challenges, the potential payoff is great.

"I was not aware of any type-2 diabetes in my family and had no significant risk factors," said Snyder, "but we learned through genomic sequencing that I have a genetic predisposition to the condition. Therefore, we measured my blood glucose levels and were able to watch them shoot up after a nasty viral infection during the course of the study."

As a result, he was able to immediately modify his diet and exercise to gradually bring his levels back into the normal range and prevent the ongoing tissue damage that would have occurred had the disease gone undiagnosed.

Snyder provided about 20 blood samples (about once every two months while healthy, and more frequently during periods of illness) for analysis over the course of the study. Each was analyzed with a variety of assays for tens of thousands of biological variables, generating a staggering amount of information.

The exercise was in stark contrast to the cursory workup most of us receive when we go to the doctor for our regular physical exam. "Currently, we routinely measure fewer than 20 variables in a standard laboratory blood test," said Snyder, who is also the Stanford W. Ascherman, MD, FACS, Professor in Genetics. "We could, and should, be measuring many, many thousands."

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Revolution in personalized medicine: First-ever integrative 'Omics' profile lets scientist discover, track his ...

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Jennifer Ganton jganton@ohri.ca 613-798-5555 x73325 Ottawa Hospital Research Institute

A team of researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) has been awarded $367,000 from the Canadian Institutes of Health Research (CIHR) and $75,000 from the Stem Cell Network to lead the first clinical trial in the world of a stem cell therapy for septic shock. This deadly condition occurs when an infection spreads throughout the body and over-activates the immune system, resulting in severe organ damage and death in 30 to 40 per cent of cases. Septic shock accounts for 20 per cent of all Intensive Care Unit (ICU) admissions in Canada and costs $4 billion annually. Under the leadership of Dr. Lauralyn McIntyre, this new "Phase I" trial will test the experimental therapy in up to 15 patients with septic shock at The Ottawa Hospital's ICU.

The treatment involves mesenchymal stem cells, also called mesenchymal stromal cells or MSCs. Like other stem cells, they can give rise to a variety of more specialized cells and tissues and can help repair and regenerate damaged organs. They also have a unique ability to modify the body's immune response and enhance the clearance of infectious organisms. They can be found in adult bone marrow and other tissues, as well as umbilical cord blood, and they seem to be easily transplantable between people, because they are more able to avoid immune rejection.

There has been a great deal of interest in using MSCs to treat disease, with most research so far focused on heart disease, stroke, inflammatory bowel disease and blood cancers. Hundreds of patients with these diseases have already been treated with MSCs through clinical trials, with results suggesting that these cells are safe in these patients, and have promising signs of effectiveness. MSCs are still considered experimental however, and have not been approved by Health Canada as a standard therapy for any disease.

In recent years, a number of animal studies have suggested that MSCs may also be able to help treat septic shock. For example, a recent study by Dr. Duncan Stewart, CEO and Scientific Director of OHRI (and also a co-investigator on the new clinical trial) showed that treatment with these cells can triple survival in a mouse model of this condition.

"Mesenchymal stem cell therapy appears promising in animal studies, but it will require many years of clinical trials involving hundreds of patients to know if it is safe and effective," said Dr. Lauralyn McIntyre, a Scientist at the OHRI, ICU Physician at The Ottawa Hospital, Assistant Professor of Medicine at uOttawa and a New Investigator with CIHR and Canadian Blood Services. "This trial is a first step, but it is a very exciting first step."

As with all "Phase I" trials, the main goal of this study is to evaluate the safety of the therapy and determine the best dose for future studies. The 15 patients in the treatment group will receive standard treatments (such as fluids, antibiotics and blood pressure control), plus a planned intravenous dose of 0.3 to 3 million MSCs per kg of body weight. The MSCs will be obtained from the bone marrow of healthy donors and purified in the OHRI's Good Manufacturing Practice Laboratory in the Sprott Centre for Stem Cell Research. The researchers also plan to evaluate 24 similar septic shock patients who will receive standard treatments only (no MSCs). All patients will be rigorously monitored for side effects, and blood samples will be taken at specific time points to monitor the cells and their activity. This trial will not be randomized or blinded and it will not include enough patients to reliably determine if the therapy is effective. It will be conducted under the supervision of Health Canada and the Ottawa Hospital Research Ethics Board, and will have to be approved by both of these organizations before commencing.

"The OHRI is rapidly becoming known as a leader in conducting world-first clinical trials with innovative therapies such as stem cells," said Dr. Duncan Stewart, CEO and Scientific Director of OHRI, Vice-President of Research at The Ottawa Hospital and Professor of Medicine at uOttawa. "This research is truly pushing the boundaries of medical science forward, and is providing the citizens of Ottawa with access to promising new therapies."

"The Canadian Institutes of Health Research (CIHR) is very pleased to support this clinical trial," said Dr. Jean Rouleau, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health. "The work of Dr. McIntyre and her colleagues will not only add to our growing knowledge of the benefits of stem-cell therapies, but will hopefully lead to treatments that can help save the lives of patients where currently, our treatment options are less than optimal."

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Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today reported the financial results for the year ended December 31, 2011 and provided a business update.

InVivo has pioneered a new treatment that uses a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovering and prognosis after a traumatic spinal cord injury. Today, there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential is estimated to be over $10 billion.

2011 was a landmark year for InVivo, performing under budget for the sixth consecutive year. We made significant progress advancing the commercialization of our first product for SCI and expanding our product pipeline to the rest of the nervous system. We also laid the groundwork to have three product applications under review by FDA by the end of 2012, said Frank Reynolds, InVivos Chief Executive Officer. Our biopolymer scaffolding is poised to enter human clinical trials for SCI during the second half of 2012 and we expect to file two additional Investigational Device Exemptions for our hydrogel products to treat both SCI and chronic pain from peripheral nerve injuries. Weve had a great start to 2012 by closing an oversubscribed $20 million public offering led by globally-recognized healthcare investment institutions and by adding key leadership to our senior management team.

Recent Corporate Highlights

Biopolymer Scaffolding Scheduled to Enter Clinical Studies for SCI in 2012: InVivo expects to commence a pilot human clinical trial during the second half of 2012 pending approval of an Investigational Device Exemption (IDE) application by the FDA. The study will be an open label study and is designed to evaluate the safety and efficacy in ten SCI patients following treatment with the biopolymer scaffolding. This study follows promising pre-clinical studies completed in non-human primates. InVivo is the first to successfully demonstrate functional improvement in non-human primates that were paralyzed after a spinal cord injury model. Data from this study was published in the Journal of Neuroscience Methods and won the prestigious 2011 Apple Award from the American Spinal Injury Association recognizing excellence in SCI research.

IDE Submissions to be Filed with FDA for Injectable Hydrogel to Treat Peripheral Nerve Injuries and SCI: InVivo has commenced a preclinical study with Geisinger Health System to evaluate the Companys injectable biocompatible hydrogel for the treatment of chronic pain caused by peripheral nerve compression. Approximately 3.2 million pain injections are performed annually to treat back, neck and leg pain caused by peripheral nerve compression. InVivos hydrogel is designed to time-release anti-inflammatory drugs for extended pain relief. The product addresses a $15 billion market for peripheral nerve injuries. InVivo expects to file two IDEs in the second half of 2012 for the use of the injectable hydrogel to treat peripheral nerve injuries and SCI.

Raised $23 Million of Equity Capital: In February 2012, InVivo completed a $20 million public offering led by a select group of institutional investors. The Company issued 9,523,810 shares of common stock at a price to the public of $2.10 per share. Net proceeds to InVivo were approximately $18.1 million. In December 2011, InVivo completed a private placement of common stock and warrants with an existing institutional investor that raised $2 million of net proceeds. In the fourth quarter of 2011, warrants with an exercise price of $1.40 per share were exercised providing $1 million of cash. InVivo has the potential to receive an additional $18.6 million from the exercise of warrants.

Key Additions to the Senior Management Team: InVivo announced the appointments of Edward Wirth III, MD, PhD, formerly of Geron, as its Chief Science Officer, Brian Hess, formerly of Stryker, as Director of Product Development, and Jonathan Slotkin, MD as Medical Director.

Opening New Corporate Headquarters including Manufacturing & Research Facilities: In December 2011, InVivo executed a multi-year lease for a 21,000 square foot facility at One Kendall Square in Cambridge, MA. The new facility will house corporate offices, lab space, a rodent vivarium and a cGMP clean room to meet the needs for the planned human clinical studies.

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InVivo Therapeutics Reports 2011 Financial Results, Provides Business Update

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

LEUVEN, BELGIUM--(Marketwire -03/15/12)- TiGenix NV (EURONEXT: TIG) today gave a business update and announced financial results for the full year 2011.

Business highlights

Financial highlights

"TiGenix has created a new and strong basis in 2011 on which we can build going forward and we have strengthened our position as the European leader in cell therapy," says Eduardo Bravo, CEO of TiGenix. "We have delivered on our promises: we have obtained national reimbursement for ChondroCelect in Belgium and made progress in other European markets. We advanced all clinical stem cell programs on plan, and raised substantial funds from specialized healthcare investors and through non-dilutive financing. Today, TiGenix is well-positioned to reach the next value-enhancing inflection points."

Business Update

Successful integration of Cellerix reinforces leadership position in cell therapyIn May 2011, TiGenix closed the business combination with the stem cell therapy company Cellerix, creating the European leader in cell therapy. During 2011 the Company succeeded in rapidly integrating both entities. The Company now combines top line revenues with an advanced pipeline of clinical stage regenerative and immuno-modulatory products. TiGenix's operations are supported by a strong commercial and manufacturing infrastructure for advanced cell therapies, an experienced international management team and a solid cash position.

As a result of the merger, the Company's development focus has shifted from early stage preclinical programs towards a number of highly promising clinical stage products for inflammatory and autoimmune disorders of high unmet medical need, each addressing markets in excess of EUR 1 billion. TiGenix product pipeline is based on a proprietary stem cell platform that exploits expanded allogeneic (donor-derived) adult stem cells derived from human adipose (fat) tissue ('eASCs'). The platform has been extensively characterized in line with requirements of the European Medicines Agency (EMA) and is supported by exhaustive preclinical and CMC packages.

Given its focus on cell therapy, TiGenix is in the process of divesting its ChondroMimetic franchise, which is based on a biomaterial platform. To be able to concentrate on its core business and move forward with a clean slate, TiGenix has decided to write-off the intellectual property related to the OrthoMimetics acquisition.

ChondroCelect commercial roll-out progressing with first national reimbursementChondroCelect obtained reimbursement in Belgium in May 2011, and is today available in 22 specialized treatment centers.

TiGenix is selling ChondroCelect in the UK, the Netherlands, Germany, and Spain under managed access and private insurance schemes, while pursuing national reimbursement in these countries and France.

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TiGenix Reports Full Year 2011 Financial Results

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By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) Marker Gene Technologies today announced a three-year, $1.6 million grant from the National Institutes of Health to further the company's screening technology directed at drugs for lysosomal storage disease.

The Eugene, Ore.-based company will use the Phase II Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke to develop live cell and tissue assays to screen drug candidates using fluorogenic, targeted substrate reporters of lysosomal enzyme activity.

According to the grant abstract, in Phase I work, MGT established the feasibility of its technology "by preparing new fluorogenic glycosidase, esterase, phosphatase, lipase and sulfatase substrates for lysosomal enzymes and demonstrated differential staining in living cells that were from normal or were of disease origin or upon induction of inhibition of lysosomal enzyme activities."

In the next phase of research funded by the Phase II grant, the new substrates will be assayed in vitro "for their ability to measure specific and localized inhibition or induction of lysosomal enzymes in living cells as well as differentiate individual enzyme activities in a cell- or tissue-specific manner."

MGT will also validate the new systems for use in high-throughput screening for drug discovery and for use in clinical diagnostics for evaluating the occurrence and progression of disease and monitoring the effectiveness of therapeutic treatments.

Lysosomal storage diseases are metabolic disorders of the nervous systems and include Tay-Sachs, Gaucher's, and Niemann-Pick disease. About one in every 100,000 people has a lysosomal storage disease, MGT said.

"The new substrates and the resulting detection systems will provide innovative methods to quantitate lysosomal enzyme function and to screen for the influence of secondary drug or protein administration, making them useful medical research tools for a variety of significant biochemical and medical applications," MGT President and CEO John Naleway said in a statement.

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Marker Gene Gets $1.6M SBIR Grant to Build Out Screening Tech for Lysosomal Storage Disease